NCT00313846

Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 529 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Detailed description

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Buprenorphine transdermal patch	Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
DRUG	Placebo	Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.

Timeline

• Start date: 2003-04-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2006-04-12
• Last updated: 2012-09-03
• Results posted: 2010-09-28

Locations

44 sites across 1 country: United States